Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor...

October 17, 2011 - Midmark Corporation partners with Cleveland Medical Devices Inc., introducing Portable Home Sleep Testing Monitor that enables patients to be tested for Obstructive Sleep Apnea in comfort of their own homes

- The FDA-cleared, physician-prescribed SleepView® provides a convenient and cost-effective alternative for diagnosing the most common type of breathing-related sleep disorder -

Midmark Corporation, a trusted leader in digital diagnostic devices for ambulatory care, announced a partnership with Cleveland Medical Devices, a leader in sleep diagnostics technology, launching the Midmark SleepView® Monitor and SleepViewSM Portal.

The Midmark SleepView Monitor developed by Cleveland Medical Devices is the market’s smallest and lightest portable home sleep monitor that meets the American Academy of Sleep Medicine’s recommended channel set for Type III monitors.

The Midmark SleepView Portal offers prescribing physicians secure, HIPAA compliant online access to registered polysomnographic technologists and board-certified sleep physicians who provide scoring, professional interpretation and treatment recommendations.

Obstructive sleep apnea (OSA) is a repeated interruption of normal breathing during sleep due to a collapse of the upper airway. It is estimated to impact as many people as asthma and diabetes; yet, 85 percent of the population with the disease is undiagnosed and untreated. "There is a real need in the healthcare industry to address this large and growing clinical concern," said Tom Treon, senior product manager for Midmark. "We want to improve the effectiveness and efficiency of care for patients with OSA by providing another diagnostic option, which enables patients to be tested in the comfort of their own bed and convenience of their own home for a more natural night of sleep."

OSA does in fact hold serious health and economic consequences. Numerous studies link OSA to major chronic diseases such as stroke, heart failure, diabetes, obesity, hypertension and increased odds of serious car crash injuries. Economic studies have also shown that people with untreated OSA have 200 percent higher healthcare costs than similar people without OSA. Midmark has entered into a strategic partnership with Cleveland Medical Devices Inc. (CleveMed) for licensing of the SleepView technology. Established in 1990, CleveMed is a leader in sleep diagnostics technology with products serving sleep labs, institutional and home settings... Cleveland Medical Devices' press Release -

Philips : Home oxygen measurement solution for sleep and ventilation launched at ERS 2011

September 29, 2011 - Philips’ latest launch reinforces its commitment to providing monitoring solutions that support patient care at home - Home oxygen measurement solution for sleep and ventilation launched at ERS 2011 - Royal Philips Electronics (NYSE: PHG, AEX: PHI) has launched the new Oximetry Module, a home oxygen measurement device designed to monitor people diagnosed with respiratory disorders such as sleep apnea and chronic obstructive pulmonary disease (COPD) and to record their blood oxygen level by means of a single finger probe.

The Oximetry Module, which was launched during the 2011 Congress of the European Respiratory Society (ERS) in Amsterdam, is designed to help physicians to better determine whether complex respiratory events are present during a person’s period of sleep at home.

“Non-invasive ventilation (NIV) (or home ventilation) has been demonstrated to be effective treatment in some forms of respiratory failure. When starting NIV, it seems desirable to verify whether this particular form of treatment is effective and has no untoward effects. Greater insight, provided by simple cost effective monitoring tools like oximetry and other signals obtained from non-invasive positive pressure ventilation (NPPV) devices; help identify issues early in the patient’s therapy. This subsequently improves their long term outcomes and quality of life... Philips' Press Release -

Siesta Medical : 510(k) Clearance for Encore™ System

September 12, 2011 - Siesta Medical, Inc. (Private), a developer of minimally invasive surgical solutions for obstructive sleep apnea (OSA), announced today that it has received FDA 510(k) clearance for its Encore™ Tongue Suspension System for the treatment of obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a major heath problem in the United States. As many as 17 million people in the United States have moderate to severe OSA, which is characterized by frequent awakening during sleep, heavy snoring and daytime sleepiness. If left untreated, OSA has been implicated in the increased risk for cardiovascular disease, including hypertension and heart failure. Despite its prevalence and role as a cardiovascular risk factor, OSA remains largely under diagnosed.

The first line and most common treatment for OSA is continuous positive airway pressure (CPAP) treatment, utilized by an estimated three million Americans. While effective, CPAP is difficult for patients to use.

Surgical therapy for OSA is less common than CPAP therapy. Although there are approximately one million new diagnoses of OSA in the U.S. each year, there are only approximately 100,000 surgical treatments for OSA performed annually. Surgery is less prevalent as most current procedures are not highly effective, are painful to the patient and do not address tongue based obstructions. The tongue is implicated in approximately 80 percent of OSA.

The Encore™ Tongue Suspension System

The EncoreTM System is used in a minimally invasive surgical procedure where the tongue is suspended forward with the intent of preventing collapse of the airway during sleep. The procedure is performed under local or general anesthesia by Ear, Nose and Throat Specialists, also known as Otolaryngologists. During the procedure, an intra-tissue suture passer is used to place a suspension loop in the tongue which is then attached to the base of the chin with a knotless bone anchor. The EncoreTM System greatly simplifies tongue suspension and provides the surgeon excellent control of positioning and tensioning of the suspension loop.

Siesta Medical is currently planning a multi-center U.S. post-marketing study... [PDF] Siesta Medical's Press Release -

Eiken : First Field-based Molecular Diagnostic Test for African Sleeping Sickness in Sight

15 September 2011 – The Geneva-based not-for-profit foundation FIND and Japanese diagnostics company Eiken announced that a next-generation molecular test designed specifically for sleeping sickness – a deadly parasitic disease also known as human African trypanosomiasis (HAT) - is ready to enter accelerated field trials in sites across the Democratic Republic of Congo and Uganda. If all goes well, the LAMP (Loop-mediated Isothermal Amplification) test - which has completed design and development phases - will be available for clinical use in 2012.

The announcement was made at the 31st biennial of the International Scientific Council for Trypanosomiasis Research and Control (ISCTRC), in Bamako, Mali.

Designed to be suitable for use in rural African settings where the disease is most common, the LAMP test promises to dramatically improve the ability to confirm a diagnosis of sleeping sickness - even when parasites are present in low numbers - through detection of the parasite's DNA in patient samples. FIND is also exploring LAMP's utility as a tool to confirm cure after treatment of HAT, which would significantly reduce the follow-up period, and could eliminate the need for repeated lumbar punctures.

If not diagnosed and treated early, sleeping sickness inexorably progresses to a stage where the parasites enter the brain, making treatment more difficult and the likelihood of irreversible neurological damage more likely... [PDF] Eiken's Press Release -

Natus Acquires Embla, Leading Sleep Diagnostic Company

Sep 16, 2011 - Acquisition expected to add $0.08 to 2012 non-GAAP Earnings Per Share -- Natus Medical Incorporated (Nasdaq:BABY) announced that it has acquired Embla Systems LLC, a leader in the development, manufacturing, and sales of devices used in the diagnosis of sleep apnea. Embla is the largest company in the world focused solely on sleep diagnostics (Polysomnography or PSG and Home Sleep Testing). The company offers a wide spectrum of innovative sleep diagnostic solutions including Embletta home sleep testing devices and three leading PSG platforms: Sandman, REMbrandt, and RemLogic, and Enterprise Sleep Business Management Systems. This breadth of product offerings provides a unique set of tools to help optimize the efficiency of sleep labs.

Natus acquired all outstanding shares of Embla capital stock for $16.1 million in cash, exclusive of direct costs of the acquisition. Embla reported revenue of approximately $30 million for its fiscal year ended December 31, 2010.

Natus expects the acquisition will be accretive to earnings in 2012, adding $0.08 to non-GAAP earnings per share for the year. The non-GAAP results will exclude amortization of acquired intangible assets and potential restructuring and other one-time charges related to the acquisition... Natus Medical's Press Release -

Chelsea Therapeutics : New Patent for Use of Droxidopa in Fibromyalgia

Sept. 6, 2011 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia. Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -

Apnex Medical : FDA Approval for Pivotal Clinical Study for Obstructive Sleep Apnea

Aug. 2, 2011 - Apnex Medical, Inc., received investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a clinical study to evaluate the safety and effectiveness of its Hypoglossal Nerve Stimulation (HGNS®) System to treat obstructive sleep apnea (OSA). Data from this clinical study are intended to support the Pre-Market Approval (PMA) application for the HGNS System to the FDA.
"Many patients who suffer from OSA are unable to tolerate existing therapies such as continuous positive airway pressure (CPAP). The HGNS System provides a fundamentally new approach to the treatment of OSA. This study will help us further understand the potential role this device will have in treating the millions of people who suffer from OSA," said the study's co-principal investigator, Dr. Atul Malhotra, Clinical Chief, Division of Sleep Medicine, Brigham and Women's Hospital.
Sponsored by Apnex Medical, the Apnex Clinical Study is a prospective, randomized, multi-center clinical trial. It is being conducted in leading medical centers in the United States, Europe and Australia. The trial is designed to demonstrate the safety and effectiveness of the HGNS therapy in treating patients with moderate to severe OSA. To be enrolled in the study patients must not have received lasting benefit from CPAP or other OSA treatments... [PDF] Apnex Medical's Press Release -